| Micra TPS (P150033/S021) | Medtronic, Inc. | 2017-04-26 |
| Revo MRI SureScan IPG RVDR01 (P090013/S255) | Medtronic, Inc. | 2017-04-26 |
| Activa Deep Brain Stimulation Therapy System (P960009/S274) | Medtronic, Inc. | 2017-04-26 |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S061) | Dexcom, Inc. | 2017-04-26 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S018) | Medinol, Ltd. | 2017-04-26 |
| RADIESSE INJECTABLE IMPLANT (P050052/S090) | Merz North America, Inc. | 2017-04-26 |
| Revo MRI SureScan IPG (P090013/S252) | Medtronic, Inc. | 2017-04-26 |
| Advisa DR IPG A4DR01; Advisa DR MRI IPG A2DR01; Advisa SR MRI IPG A3SR01 (P980035/S496) | Medtronic, Inc. | 2017-04-26 |
| InterStim Therapy System (Urinary) (P970004/S239) | Medtronic Neuromodulation | 2017-04-26 |
| InterStim Therapy System (Bowel) (P080025/S134) | Medtronic Neuromodulation | 2017-04-26 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, SV, LL (P110019/S092) | Abbott Vascular | 2017-04-25 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000. (P010030/S086) | Zoll Manufacturing Corporation | 2017-04-25 |
| SPRINT QUATTRO MRI SURESCAN LEAD MODEL 6946M (P920015/S196) | Medtronic, Inc. | 2017-04-25 |
| Restore Spinal Cord Stimulation Systems (P840001/S356) | Medtronic Neuromodulation | 2017-04-25 |
| Attain Ability MRI / Plus / Straight SureScan Leads; Attain Performa MRI / Straight / S MRI SureScan Leads (P080006/S101) | Medtronic, Inc. | 2017-04-25 |
| AMPLIA MRI AND AMPLIA MRI QUAD CRT-D SURESCAN MODELS DTMB1D4, DTMB1QQ. COMPIA MRI, CLARIA MRI (P010031/S577) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN (P980016/S618) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Revo MRI SureScan IPG & CapSureFix MRI SureScan Lead MRI (P090013/S240) | Medtronic, Inc. | 2017-04-25 |
| SELECTSECURE MRI SURESCAN LEAD MODEL 3830 (P030036/S093) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076 (P930039/S168) | Medtronic, Inc. | 2017-04-25 |
| 4598MEDTRONIC ATTAIN ABILITY MODEL 4196, ATTAIN PERFORMA S MRI SURESCAN LEAD MODEL (P080006/S107) | Medtronic, Inc. | 2017-04-25 |
| ADVIA Centaur HBeAg (P090024/S003) | Siemens Healthcare Diagnostics | 2017-04-25 |
| Activa Deep Brain Stimulation Therapy System (P960009/S275) | Medtronic, Inc. | 2017-04-25 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S088) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI (P010031/S569) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs) (P980035/S481) | Medtronic, Inc. | 2017-04-25 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S248) | Medtronic, Inc. | 2017-04-25 |
| Sprint Quattro Secure S MRI & MRI SureScan Leads (P920015/S188) | Medtronic, Inc. | 2017-04-25 |
| CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S143) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| CapSure Sense MRI SureScan Leads (P830061/S137) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A (P980016/S609) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| OBALON BALLOON SYSTEM (P160001/S003) | Medtimo, Inc. | 2017-04-25 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S136) | Abbott Vascular, Inc. | 2017-04-25 |
| CapSureFix Novus MRI SureScan Lead (P930039/S162) | Medtronic, Inc. | 2017-04-25 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S041) | ABBOTT MEDICAL | 2017-04-24 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene- Fibrillar Form (P850010/S075) | Integra LifeSciences Corporation | 2017-04-24 |
| ECLA GlideLight Catheter (P910001/S092) | Spectranetics Corp. | 2017-04-24 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S032) | Bunnell, Inc. | 2017-04-24 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent-Microfibrillar Form (P810006/S076) | Integra LifeSciences Corporation | 2017-04-24 |
| ELCA and SLS/GlideLight Catheter (P960042/S056) | Spectranetics (Philips) | 2017-04-24 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S062) | Integra Lifesciences Corp. | 2017-04-24 |
| LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT (P160024) | Bard Peripheral Vascular, Inc. | 2017-04-24 |
| lntegraQ Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenera (P900033/S061) | Integra Lifesciences Corp. | 2017-04-24 |
| Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura (P980016/S630) | Medtronic Cardiac Rhythm Disease Management | 2017-04-23 |
| All Flex 4-Socket Hi-POT/Pulse Test System (P110042/S082) | Boston Scientific Corporation | 2017-04-23 |
| Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro (P010031/S590) | Medtronic Cardiac Rhythm Disease Management | 2017-04-23 |
| Nucleus 24 Cochlear Implant System (P970051/S159) | Cochlear Americas | 2017-04-21 |
| Animas Vibe System (P130007/S024) | Animas Corp. | 2017-04-21 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-D Resynchronization Devices (P010012/S445) | Boston Scientific Corp | 2017-04-21 |
| LATITUDE NXT Patient Management System/ LATITUDE NXT G2 Communicator (P910077/S158) | Boston Scientific | 2017-04-21 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices (P960040/S389) | Boston Scientific | 2017-04-21 |
| AIR OPTIX plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear (P010019/S054) | Alcon Laboratories, Inc. | 2017-04-21 |
| Micra Transcatheter Pacing System (P150033/S018) | Medtronic, Inc. | 2017-04-21 |
| Nucleus Hybrid L24 Implant System (P130016/S024) | Cochlear Americas | 2017-04-21 |
| Nucleus ABI541 Auditory Brainstem Implant (P000015/S019) | Cochlear Americas | 2017-04-21 |
| Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters (P100010/S064) | Medtronic Cryocath, LP | 2017-04-21 |
| Medtronic Minimed 630G System with Enlite (P150001/S011) | Medtronic Minimed | 2017-04-20 |
| NovaFlex+ Delivery System (P130009/S072) | Edwards Lifesciences, LLC | 2017-04-20 |
| 3Dimensions (P080003/S004) | Hologic, Inc. | 2017-04-20 |
| Medtronic MiniMed Hybrid Closed Loop (HCL) 670G (P160017/S010) | Medtronic Minimed, Inc. | 2017-04-20 |
| Animas Vibe System (P130007/S023) | Animas Corp. | 2017-04-20 |
| LCS Total Knee System (P830055/S181) | Depuy, Inc. | 2017-04-20 |
| Medtronic CoreValve and Medtronic Evolut Systems (P130021/S037) | Medtronic, Inc. | 2017-04-20 |
| Reshape Integrated Dual Balloon System (P140012/S009) | Boston Scientific Corporation | 2017-04-20 |
| MetriQ Irrigation Pump (P150005/S013) | Boston Scientific Corp | 2017-04-20 |
| ACUITY X4 Lead (P910073/S141) | Boston Scientific | 2017-04-19 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S089) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-04-19 |
| Mentor MenoryShape Breast Implants (P060028/S022) | Mentor Worldwide, LLC | 2017-04-19 |
| VISTAKON (senofilcon) Brand Contact Lenses (P040045/S069) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-04-19 |
| Mentor MemoryGel SiliconeGel-Filled Breast Implants (P030053/S040) | Mentor Corp. | 2017-04-19 |
| FINELINE II Sterox and Sterox EZ Lead (P960004/S079) | Boston Scientific | 2017-04-19 |
| ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE Lead (P010012/S447) | Boston Scientific Corp | 2017-04-19 |
| Edwards Commander Delivery System (P140031/S037) | Edwards Lifesciences, LLC | 2017-04-19 |
| INGEVITY Lead (P150012/S027) | Boston Scientific | 2017-04-19 |
| Aaris intraocular lens model EC-3 and EC-3 PAL (P100016/S003) | Carl Zeiss Meditec Production, LLC | 2017-04-18 |
| AngioSculpt RX PTCA Scoring Balloon Catheter (P050018/S024) | Spectranetics Corp. | 2017-04-17 |
| BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses (P080011/S056) | CooperVision, Inc. | 2017-04-17 |
| LATITUDE NXT Release 5.0 (P910077/S156) | Boston Scientific | 2017-04-17 |
| Arctic Front Family of Catheters (P100010/S063) | Medtronic Cryocath, LP | 2017-04-17 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA ICD's (P960040/S384) | Boston Scientific | 2017-04-17 |
| Freezer Cardiac Cryoablation, Freezer Xtra Surgical Cardiac, Freezer MAX Surgical Cardiac (P020045/S082) | Medtronic Cryocath, LP | 2017-04-17 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 PACEMAKER's (N970003/S197) | Boston Scientific Corp | 2017-04-17 |
| EXABLATE (P150038/S002) | Insightec | 2017-04-17 |
| FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire (P110016/S040) | ABBOTT MEDICAL | 2017-04-17 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza (P010012/S435) | Boston Scientific Corp | 2017-04-17 |
| INVIVE, INTUA, VISIONIST, VALITUDE CRT-P's Resynchronization Devoces (P030005/S145) | Guidant Corp. | 2017-04-17 |
| EMBLEM SUBCUTANEOUS ICD's (P110042/S068) | Boston Scientific Corporation | 2017-04-17 |
| Impella Ventricular Support Systems (P140003/S016) | Abiomed, Inc. | 2017-04-17 |
| Model 7010 Sensor and Model 7510 Driver transducers (P090018/S035) | Envoy Medical Corporation | 2017-04-14 |
| Ambicor Inflatable Penile Prosthesis. (N970012/S133) | Boston Scientific Corp | 2017-04-14 |
| IMPELLA 2.5 SYSTEM (P140003/S014) | Abiomed, Inc. | 2017-04-14 |
| Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/ Brava Quad CRT-D/ Claria MRI CRT-D/ Claria MRI Quad CRT-D/ Compia M (P010031/S583) | Medtronic Cardiac Rhythm Disease Management | 2017-04-14 |
| Belotero Balance Dermal Filler (P090016/S023) | Merz North America, Inc. | 2017-04-14 |
| Absolute Pro Vascular Self-Expanding Stent System. (P110028/S017) | Abbott Vascular, Inc. | 2017-04-14 |
| MiniMed 630G System with SmartGuard (P150001/S013) | Medtronic Minimed | 2017-04-14 |
| Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S624) | Medtronic Cardiac Rhythm Disease Management | 2017-04-14 |
| EMBLEM S-ICD Model A209; EMBLEM MRI S-ICD Model A219 (P110042/S081) | Boston Scientific Corporation | 2017-04-13 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S037) | Mentor Corp. | 2017-04-13 |
| SynchroMed Implantable Infusion System (P860004/S270) | Medtronic, Inc. | 2017-04-13 |
| MitraClip NT Clip Delivery System (P100009/S022) | ABBOTT MEDICAL | 2017-04-13 |